- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06954896
Comparison of Superior Hypogastric Plexus Block and Peritoneal Bupivacaine in Pain Management
Comparison of Superior Hypogastric Plexus Block and Peritoneal Bupivacaine in Pain Management After Laparoscopic Hysterectomy
Background: Laparoscopic hysterectomy is one of the most frequently performed major surgeries in nonmalignant gynecological diseases. Effective postoperative analgesia is associated with short hospital stays, early mobilization, reduced costs, and patient satisfaction. Intravenous administration of nonsteroidal anti-inflammatory drugs, paracetamol or opioids; epidural catheter placement; peritoneal local anaesthetic administration; and superior hypogastric plexus block (SHPB) are routinely employed methods for postoperative pain management following laparoscopic hysterectomy.
Methods: The study population comprised patients who underwent laparoscopic hysterectomy with or without oophorectomy for benign indications. A total of 94 patients were included in the study. Thirty patients received a superior hypogastric plexus block, thirty received intraperitoneal local anaesthetic spray, and thirty-four received intravenous analgesics.
Conclusion: In the present study, a comparison of postoperative pain management in patients who underwent laparoscopic hysterectomy was conducted.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Mardin, Turkey
- Mardin Artuklu University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients who underwent laparoscopic hysterectomy-with or without oophorectomy-
- ASA physical status I-II patients
Exclusion Criteria:
- women with known bupivacaine allergy, anxiety-depressive disorders, fibromyalgia, coagulopathy, eclampsia/preeclampsia, or those who were pregnant were also excluded.
- if they were younger than 18 or older than 65
- underwent epidural catheterisation and/or received additional pain management modalities
- prescribed preoperative antidepressants or gabapentinoids
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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intraperitoneal local anaesthetic spray (Group B)
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The peritoneal cavity and abdominal wall were treated with 30 milliliters of 0.25% bupivacaine, with a focus on areas involving the peritoneum in the lower abdominal region.
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intravenous analgesics (Group C)
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In cases where the VAS score exceeded 3 in the postoperative period, it was deemed that the patient's analgesia was insufficient, prompting the intravenous administration of 50 mg of dexketoprofen sodium.
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superior hypogastric plexus block (Group S)
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The superior hypogastric plexus block (SHPB) was performed following uterine removal and closure of the vaginal cuff, but prior to trocar removal from the abdominal cavity.
The promontory was identified under laparoscopic visualization.
The posterior peritoneum overlying the promontory was gently grasped and elevated with an instrument to create a peritoneal tent.
A needle was then inserted at the apex of the tent and advanced approximately 1 cm.
At this point, a subperitoneal space was further expanded using a surgical instrument, and 30 ml of 0.25% bupivacaine was injected into the area
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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VAS (vısual analog scale)
Time Frame: 24 HOUR
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For patients with no pain, VAS was recorded as 0 (zero), and for those with unbearable pain, VAS was recorded as 10 (ten).
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24 HOUR
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Peripheral Nervous System Agents
- Antirheumatic Agents
- Anesthetics, Local
- Anesthetics
- Central Nervous System Depressants
- Sensory System Agents
- Analgesics, Non-Narcotic
- Analgesics
- Anti-Inflammatory Agents, Non-Steroidal
- Bupivacaine
- Dexketoprofen trometamol
Other Study ID Numbers
- ArtukluU-MED-EC-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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